Kornimate/medical-research-clean huggingface dataset:
phase i study of fractionated stereotactic radiation therapy

Conditions: Brain Metastases

Summary: there is a lack of prospective trial data and consensus guidelines describing the use of fractionated stereotactic radiation therapy (fsrt) in the treatment of brain metastases. there has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (mtd) in patients treated with fsrt. prescription doses in the series described above ranged from 18 gy to 42 gy, delivered in 3 to 12 fractions. the results of this study will be used to plan future phase ii/iii studies to determine the efficacy of different dose fractionation schedules of fsrt. the investigator team thus proposes a phase i study to determine the feasibility and safety of fsrt in patients with brain metastases.


Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration * intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced mri obtained within 30 days prior to registration or surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension * prior whole brain radiation therapy (wbrt) is allowed * age ≥ 18 years * women of childbearing potential and male participants must practice adequate contraception * history/physical examination within 30 days prior to registration * life expectancy \>3 months * patients are allowed to enroll if previously treated to other lesions with stereotactic radiosurgery (srs) * patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with fsrt. other lesions may be treated concurrently with srs or fsrt at the discretion of the treating physician but will not contribute to the study endpoints exclusion criteria: * patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (csf) examination * plan for chemotherapy or targeted agents during treatment. hormonal therapy, immunotherapy targeting pd-1/pd-l1 axis, and bone supportive therapy may be continued during treatment * contraindication to enhanced mri imaging such as implanted metal devices. however, patients with implanted devices which are mri compatible are allowed * patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy * uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity * previous treatment of the target lesion with radiotherapy
efficacy and safety of yuxuebi tablet in treating night pain of ankylosing spondylitis (as).

Conditions: Ankylosing Spondylitis

Summary: this study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of yuxuebi tablet in treating night pain of ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: 1. ages 18-65, male or female 2. confirmed diagnosis of ankylosing spondylitis 3. syndrome of traditional chinese medicine is blood stasis syndrome 4. asdas-crp (ankylosing spondylitis disease activity score)≥2.1 5. visual analogue scale (vas) for night pain≥4分 6. maintained stable doses of sulfasalazine, methotrexate, leflunomide, etc. for more than 1 month if treating with slow-acting antirheumatic drugs 7. maintained stable doses of biologics for more than 3 month if treating with biologics 8. not use nonsteroidal antiinflammatory drugs within 2 weeks 9. patients who have not participated in other clinical trials within 4 weeks 10. written informed consent exclusion criteria: 1. pregnant or breastfeeding or who expecting to conceive 2. psoriatic arthritis or enteropathic arthritis 3. as with iritis or uveitis 4. abnormal liver function 5. abnormal kidney function，high level of creatinine 6. wbc (white blood cell)\<3.0×10\^9/l or with hematological disease 7. patients with poor control of hypertension or diabetes 8. acute or chronic infectious diseases 9. severe arrhythmia 10. patients with malignant tumors or with a history of malignant tumors 11. drug allergy 12. patients who had taken yuxuebi tablet for more than 4 weeks with poor outcome 13. patients who are treating with traditional chinese medicine for promoting blood circulation and removing blood stasis 14. alcohol or drug abuse 15. participants who are not suitable for clinical trial under doctors' consideration.
prospective observational study of patients with polycythemia vera in us clinical practices (reveal)

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: this is a phase iv, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt pv and are being followed in either community or academic medical centers in the united states who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.


Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of polycythemia vera (pv) * willing and able to provide written informed consent * willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel * under the supervision of a physician for the current care of pv including but not limited to watchful waiting, acetylsalicylic acid (asa) 81mg or greater, antithrombotic therapy, phlebotomy (phl), hydroxyurea (hu), interferon (recombinant or pegylated), busulfan, anagrelide exclusion criteria: * participation in an active clinical trial in which the study treatment is blinded * life expectancy \<6 months * diagnosis of myelofibrosis (mf) \[including primary mf, post-pv mf, or post-essential thrombocythemia mf (post-et mf)\] * diagnosis of secondary acute myeloid leukemia (aml) * diagnosis of myelodysplastic syndrome (mds) * history of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months * splenectomy

Keywords: polycythemia polycythemia vera hematologic diseases myeloproliferative disorders bone marrow diseases hydroxyurea antineoplastic agents therapeutic uses pharmacologic actions antisickling agents hematologic agents enzyme inhibitors molecular mechanisms of pharmacological action nucleic acid synthesis inhibitors
thora-3di™ for evaluation of severity of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to demonstrate differences in tidal breathing patterns measured by slp(structured light plethysmography) between healthy subjects and copd (chronic obstructive pulmonary disease). the correlation between slp parameters and standard lung function parameters measured by body box and spirometry will also be assessed. trends in slp breathing patterns between the different gold (global initiative for chronic obstructive lung disease) stages of copd, and between those and healthy subjects, will be investigated to assess whether slp can detect differences between groups.

structured light plethysmography (slp) is a novel, non-contact method for assessing quiet 'tidal' breathing. a number of studies have reported the effects of conditions such as chronic obstructive pulmonary disease (copd) on tidal breathing patterns, and a previous study has shown that slp is able to detect differences in ten tidal breathing patterns between healthy subjects and patients with copd. in this present study, the investigators will aim to confirm the previous findings and also to examine the relationship between slp tidal breathing parameters and traditional measurements of lung function measured by spirometry and body box plethysmograph. the correlation between slp parameters with lung function parameters measured by spirometry and body box plethysmography: forced expiratory volume in one second (fev1); forced vital capacity (fvc), fev1/fvc (forced expiratory volume in one second/forced vital capacity); total lung capacity (tlc) and residual volume (rv). trends in tidal breathing patterns between varying severities of copd (based on the (global initiative for lung disease (gold) grading system.

Eligibility criteria:
inclusion criteria: * age range 18-80 years, * bmi range 18-40 kg/m2 * patients diagnosed, or suspected, with copd or normal subjects with no previous or current diagnosis of respiratory disease exclusion criteria: * patient unable to sit in an upright position for required period of time * patients with significant co morbidities (assessed by the clinician at screening only): * significant unilateral lung disease e.g. pneumonectomy * chest wall or spinal deformity e.g. scoliosis * obstructive sleep apnea (osa), apnoea hypopnoea index \> 30 (if known) * bmi\>40 * inability to consent/comply with trial protocol * presence of an acute disease process that might interfere with test performance, e.g. nausea, vomiting, persistent coughing)

Keywords: copd, structured light plethysmography, copd severity
study of fx006 for the treatment of pain in patients with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study was to assess the safety and efficacy of fx006 for the treatment of pain in patients with osteoarthritis of the knee.

this study was a double-blind, randomized, single dose design. the study was conducted in male and female patients ≥40 years of age with oa of the knee. approximately 450 patients with oa of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single ia injection of: * 32 mg fx006, * normal saline (placebo), or * 40 mg tca ir. randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (adp) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7. each patient was evaluated for a total of 24 weeks following a single ia injection. following screening, safety and efficacy were evaluated at 7 out-patient visits (days 1 \[baseline\], weeks 4, 8, 12, 16, 20, and 24). the study was expected to enroll in approximately 6 months.

Eligibility criteria:
inclusion criteria: * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * male or female \>=40 years of age * has symptoms associated with oa of the index knee for at least 6 months prior to screening * currently meets american college of rheumatology (acr) criteria (clinical and radiological) for oa * kellgren-lawrence (k-l) grade 2 or 3 in the index knee per screening x-ray * index knee pain for \> 15 days over the last month * qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) * body mass index (bmi) ≤ 40 kg/m2 * willingness to abstain from use of restricted medications exclusion criteria: * any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iipsilateral hip oa, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain) * fibromyalgia, reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease * history of infection in the index knee * clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of screening * unstable joint within 12 months of screening * ia corticosteroid (investigational or marketed) in any joint within 3 months of screening * ia hyaluronic acid (investigational or marketed) in the index knee within 6 months of screening * intramuscular (im) or oral corticosteroids (investigational or marketed) within 1 month of screening * any other ia investigational drug/biologic within 6 months of screening * prior use of fx006 * women of child-bearing potential not using effective contraception or who are pregnant or nursing

Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
oa clinic-community care model

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Overweight; Obesity; Physical Inactivity; Weight Loss

Summary: the purpose of this study is to test the oa clinic-community care model (oa care) which will address all recommended components of knee/hip (osteoarthritis) oa care, include interventions for both patients and primary care providers (pcps), and utilize a tailored approach that efficiently matches treatments with patients' needs. the patient component of oa care will include evidence-based weight management and exercise programs for all participants (delivered through the ymca), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services. the pcp component of oa care will include a video-based summary of current oa treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.

this study will be a randomized pilot trial of oa care among n=60 patients with knee and/or hip osteoarthritis (oa) and overweight/obesity who are not currently meeting physical activity recommendations. participants will be randomly assigned to oa care or a usual care (uc) group. assessments will be conducted at baseline, 6 months and 12 months. primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (pa), measured via accelerometer.

Eligibility criteria:
inclusion criteria: * clinician diagnosis of knee or hip oa * self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week * current weekly physical activity \<150 minutes per week * body mass index (bmi) ≥27 kg/m\^2 exclusion criteria: * no internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention * pain in chest when performing physical activity * pain in chest when not performing physical activity * no documented diagnosis of knee or hip oa * total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months * dementia or other memory loss condition * active diagnosis of psychosis * active substance abuse disorder * severe hearing or visual impairment * serious/terminal illness as indicated by referral to hospice or palliative care * hospitalization for cardiovascular event in last 6 months * history of ventricular tachycardia * unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen) * stroke with moderate to severe aphasia * recent history (last 6 months) of three or more falls * planning total joint replacement in next 6 months * any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss * current participation in other study related to knee or hip osteoarthritis or physical activity * unable to speak english
evaluation of kidney graft's fibrosis with real time shear-wave elastography

Conditions: Kidney Graft

Summary: kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. actually, that evaluation is based on histologic score of banff fi/at (0 to iii). it is obtained thanks to punction-biopsy, which is invasive and can lead complications. this exam is systematic on m3 of the transplantation. tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity. elastography is an ultrasound technique allowing evaluation of tissues' rigidity. the purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically shear wave elastography (swe). for this, strain ratio (sr) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. actually, that evaluation is based on histologic score of banff fi/at (0 to iii). it is obtained thanks to punction-biopsy, which is invasive and can lead complications. this exam is systematic on m3 of the transplantation. tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity. elastography is an ultrasound technique allowing evaluation of tissues' rigidity. the purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically shear wave elastography (swe). for this, strain ratio (sr) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

Eligibility criteria:
inclusion criteria: * kidney-transplanted patient, whatever kind of organ donation ( alive donor, deceased donor included extended criteria maastricht 2 or 3) * more than 18 years-old exclusion criteria: * dual kidney graft * hydronephrosis / urinary obstacle * pathologies with an intrinsic compression on the graft * stenosis hemodynamically significant of graft artery (lengthening of systolic ascent time \> 70 ms) * contra-indication to systematical punction-biopsy on month 3 : * ischemia of post-transplanted graft * alive donor hla identical * hemostasis disorder or unable to stop antiaggregant or anticoagulant * hydronephrosis / urinary obstacle * opposition to use the data

Keywords: kidney graft fibrosis elastography
elderly patients and covid-19 infection: a cohort of fifty patients over ninety years of age

Conditions: Covid19

Summary: sars-cov2 or covid19 disease is a newly described pathology linked to a subtype of the coronavirus family identified in china in december 2019. this pathology can present multiple clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms called "acute respiratory distress syndrome". the elderly population is more at risk for this infection due to the senescence of the immune system, co-morbidities and poly medications. they also often present a greater state of fragility. this study aims to report the epidemiology of the first 50 patients over 90 years of age hospitalized within the chu brugmann hospital.


Eligibility criteria:
inclusion criteria: * be over 90 years of age on the date of admission to chu brugmann hospital * have a sars cov2 infection proven by antigen or rt-pcr on smear and / or typical imaging regardless of the clinical manifestation * have been hospitalized at chu brugmann between 03/01/2020 and 05/10/2020 exclusion criteria: none
genetic factors and interrelationships for cancer risk-related behaviors and complex traits

Conditions: Acquired Immunodeficiency Syndrome; Alcoholism; HIV Infection; Neoplasm; Smoking

Summary: we propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. the main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and hiv/aids susceptibility and progression. the subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. information on tobacco and alcohol use, psychological and personality traits, sexual behavior, hiv status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. dna will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. by correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.

we propose to conduct a multifactorial genetic study of cancer risk-related behaviors and other complex human characteristics. the main areas of interest are tobacco smoking, excess alcohol consumption, psychological traits, and hiv/aids susceptibility and progression. the subjects will be adult male and female probands who display one or more of the phenotypes of interest together with their brothers, sisters and parents. information on tobacco and alcohol use, psychological and personality traits, sexual behavior, hiv status and progression, and other characteristics with possible genetic components will be obtained through structured interviews and questionnaires. dna will be prepared from blood samples and typed for a series of candidate genes chosen for function and for random polymorphic markers. by correlating the genotypic and phenotypic information, we hope to identify individual loci that interactively contribute to many different aspects of human health and disease.

Eligibility criteria:
inclusion criteria: the basic requirement for entry in the study will be the presence of any individual smoker who is willing to complete the evaluation process and donate a blood sample. additional siblings will be encouraged but not required to participate. probands will be recruited through smoking cessation programs at the national naval medical center. attendees at programs offered by the health promotions department and the military family health center will be invited to participate in this study. exclusion criteria: all subjects will be adults (greater than 18 years). there will be no exclusions based on sex, ethnic group, or race.

Keywords: smoking alcohol hiv aids dna markers personality healthy volunteers normal volunteer
effectiveness of education to keep the abdomen relaxed versus contracted during pilates

Conditions: Low Back Pain

Summary: this study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during pilates exercises in patients with primary chronic low back pain. participants will be randomised into two groups that will be treated with pilates exercises for 12 weeks. the control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. primary outcomes will be pain intensity and disability 12 weeks post randomisation.


Eligibility criteria:
inclusion criteria: * aged from 18 years old; * low back pain for more than 3 months; * disability level ≥ 4 points on the roland-morris disability questionnaire (rmdq); * ability to move independently with or without assistance; * ability to understand portuguese enough to be able to fill in the questionnaires. exclusion criteria: * the main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis); * surgery performed on the lumbar spine. * surgery performed on the lower limbs, or abdominal region less than 6 months ago; * performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months; * diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of pain; * scoliosis as the primary cause of pain; * unstable heart conditions; * presence of red flags such as malignancy/cancer, acute trauma (less than 6 months), infection, spinal cord/cauda equina compression.